Condition category
Eye Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
28/12/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P W Y de Waard

ORCID ID

Contact details

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31(0)10 401 7777
deWaard@oogziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OZR-2006-01

Study information

Scientific title

Acronym

Study hypothesis

A single subconjunctival Celestone chronodose injection immediately following cataract extraction reduces the incidence of post-operative ocular inflammation when compared with conventional post-operative eye drops therapy.

Post-op administration of eserine does not reduce the incidence of dislocation of the intraocular lens implant any further.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cataract

Intervention

Group 1: subconjunctival steroid injection.
Group 2: topical steroids (three times per day during three weeks).
Group 3: as group two plus Eserine.
Group 4: as group one plus Eserine.

Intervention type

Drug

Phase

Not Specified

Drug names

Steroids, Celestone chronodose and Eserine

Primary outcome measures

1. Laser flarecount, examined by laser flarecounter, before operation and on day 21.
2. Thickness of the macula, examined by Optical Coherence Tomography (OCT), before operation and on day 21.

Secondary outcome measures

1. Number of extra visits due to complaints of post-op irritation.
2. Number of patients with macular edema, examined by OCT, on day 21.
3. Intraocular pressure on day one and 21.
4. Number of extra visits due to complaints of reduced visual acuity (miotic wearing off).
5. Pain (scaling one to ten) on day one.
6. Incidence of anterior synechiae (gonioscopic evaluation) on day 21.
7. Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart on day 21.

Overall trial start date

01/01/2007

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cataract extraction indication
2. Aged over 18 years
3. Caucasian - informed consent
4. Post-op follow-up must be feasible

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

1. Subcapsular posterior cataract (very soft, short phaco time)
2. Brunescens or mature cataract (hard, long phaco time)
3. Diabetes mellitus
4. Age-related macula degeneration
5. History of uveitis
6. Glaucoma
7. History of steroid response
8. Per-operative iris manipulation (e.g. miosis or posterior synechiae)
9. Pre-operative synechiae anterior
10. Systemic steroid medication
11. Chemotherapy
12. Peroperative contact with vitreous
13. Sickle cell anemia
14. Corneal complications
15. Atopy
16. Herpes Simplex Virus (HSV)

Recruitment start date

01/01/2007

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands

Sponsor information

Organisation

The Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (OZR) (The Netherlands)

Sponsor details

P.O. Box 70030
Rotterdam
3000 LM Rotterdam
Netherlands
+31 (0)10 401 7777
info@oogziekenhuis.nl

Sponsor type

Hospital/treatment centre

Website

http://www.oogziekenhuis.nl/

Funders

Funder type

Research organisation

Funder name

Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes